MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40Q

Device Problem Programming Issue (3014)

Patient Problems Therapeutic Response, Increased (2272); Palpitations (2467)

Event Date 06/02/2017

Event Type  Injury  

Event Description

It was reported that a patient presented in clinic with palpitations.Upon review, it was noted that the cardiac resynchronization therapy defibrillator exhibited several episodes of pacemaker mediated tachycardia caused by a retrograde pathway.Programming changes to decrease atrial sensitivity were made.The issue was resolved.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6685079
• MDR Text Key: 79024476
• Report Number: 2017865-2017-05961
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3380791
• Other Device ID Number: 05414734504393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR